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Kurinchi Selvan Gurusamy, Lawrence Mj Best, Cynthia Tanguay, Elaine Lennan, Mika Korva, Jean-François Bussières
BACKGROUND: Occupational exposure to hazardous drugs can decrease fertility and result in miscarriages, stillbirths, and cancers in healthcare staff. Several recommended practices aim to reduce this exposure, including protective clothing, gloves, and biological safety cabinets ('safe handling'). There is significant uncertainty as to whether using closed-system drug-transfer devices (CSTD) in addition to safe handling decreases the contamination and risk of staff exposure to infusional hazardous drugs compared to safe handling alone...
March 27, 2018: Cochrane Database of Systematic Reviews
Silvia Valero, Eduardo López-Briz, Nieves Vila, Antonio Solana, Mar Melero, Jose Luis Poveda
Assuring healthcare workers security on Hazardous Drugs (HD) compounding is critical in healthcare settings. Our study aims to demonstrate that the use of a Close System drug Transfer Device (CSTD) PhaSeal™ added to a decontamination process reduces antiblastic surface contamination levels in the Compounding Area (CA) of our Pharmacy Department (PD). We selected cyclophosphamide, 5-fluorouracil and iphosphamide to be evaluated. Testing was carried out with a wipe kit and quantified by an independent laboratory...
March 3, 2018: Regulatory Toxicology and Pharmacology: RTP
Nicolas Simon, Michèle Vasseur, Marine Pinturaud, Marion Soichot, Camille Richeval, Luc Humbert, Michèle Lebecque, Ousseini Sidikou, Christine Barthelemy, Pascal Bonnabry, Delphine Allorge, Bertrand Décaudin, Pascal Odou
BACKGROUND: The objective of this randomized, prospective and controlled study was to investigate the ability of a closed-system transfer device (CSTD; BD-Phaseal) to reduce the occupational exposure of two isolators to 10 cytotoxic drugs and compare to standard compounding devices. METHODS AND FINDINGS: The 6-month study started with the opening of a new compounding unit. Two isolators were set up with 2 workstations each, one to compound with standard devices (needles and spikes) and the other using the Phaseal system...
2016: PloS One
Philippe Garrigue, Marc Montana, Christophe Ventre, Amandine Savry, Laurence Gauthier-Villano, Pascale Pisano, Bertrand Pourroy
Closed-system transfer devices enhance the drug handlers' protection against hazardous drugs exposure by prohibiting the escape of liquid or vapor from the system. PhaSeal (Becton Dickinson), a reference closed-system transfer device, includes a vial protector with an expansion chamber, and an injector with an enclosed needle. VialShield (CareFusion) is another more recent closed-system transfer device including an expansion-chamber and a non-return valve, designed to be used in association with Texium (CareFusion), a closed, needle-free male luer with its preassembled syringe...
March 2016: International Journal of Pharmaceutical Compounding
K Kicenuik, N Northrup, A Dawson, J Locke, J A Villamil, J Chretin, G Sfiligoi, C Clifford, M Rosenberg, T Hamilton, R Regan, M Parsons-Doherty, C Mallett, J Philibert, J Impellizeri, E Hofmeister
This prospective experimental simulation study evaluated the efficiency, ease of use (EOU) and cost of administering chemotherapy with two closed system transfer devices (CSTD, Equashield™ and PhaSeal(®) ) and no CSTD. Forty-six veterinary technicians (VT) working in oncology specialty practices were timed during chemotherapy administration simulated with water and a model canine limb 10 times with each system and with no CSTD. EOU and likelihood of recommending each system were rated by VT using visual analog scales...
March 2017: Veterinary and Comparative Oncology
Yohei Ikeno, Daisuke Arii, Hirofumi Nakajima, Kunihiko Murooka, Michio Nojima, Akio Kidokoro
The closed-system transfer device (CSTD), which is used to prevent the exposure of medical staff to anticancer drugs, has been reported to allow safe preparation and administration of these drugs to patients. At many medical institutions, however, the use of such devices is limited to select anticancer drugs. This could be attributable to the longer preparation time compared to the conventional injection technique with a syringe and needle, as well as the fact that the anticancer drugs are too expensive to be covered by the remuneration available for medical services...
May 2014: Gan to Kagaku Ryoho. Cancer & Chemotherapy
Stephen T Smith, Mark C Szlaczky
AIM: The purpose of this study was to perform a comparative cyclophosphamide contamination level test with Becton Dickinson® syringe plungers with Phaseal® Closed System Transfer Devices and Equashield® syringe plungers under routine oncological compounding conditions. METHOD: The ChemoGlo™ sampling kit and analysis services were used to test for cyclophosphamide contamination levels on the syringe plungers of Becton Dickinson® Phaseal and Equashield® syringes that underwent cycles of drug transfer in a Forma Class II, 2A Biological Safety Cabinet...
October 2014: Journal of Oncology Pharmacy Practice
Paul J M Sessink, Jason Trahan, Joseph W Coyne
PURPOSE: In a follow-up to a previous study, surface contamination with the antineoplastic drug cyclophosphamide was compared in 30 US hospital pharmacies from 2004 to 2010 following preparation with standard drug preparation techniques or the PhaSeal closed system drug transfer device (CSTD). METHODS: Wipe samples were taken from biological safety cabinet (BSC) surfaces, BSC airfoils (the front leading edge of the BSC), floors in front of BSCs, and countertops in the pharmacy, and they were analyzed for contamination with cyclophosphamide...
March 2013: Hospital Pharmacy
Michael S Edwards, Dominic A Solimando, Franklin R Grollman, Janet L Pang, Ashley H Chasick, Charlene M Hightman, Anthony D Johnson, Maxine G Mickens, Lorenzo M Preston
PURPOSE: Medication cost is a major factor associated with increasing health care costs in the United States. Expenditures for prescription drugs in 2013 are estimated to be $283.7 billion. Closed system transfer devices are widely used for preparation of hazardous drugs. Reports indicate the Phaseal(®) closed system transfer device maintains sterility in vials for 7 days, suggesting the unused portion of single-use vials could be salvaged. This study was done to determine whether using a closed system transfer device to extend the beyond-use date of single-use vials of antineoplastic medications would result in a measurable cost saving...
December 2013: Journal of Oncology Pharmacy Practice
Tomohiro Miyake, Takuya Iwamoto, Manabu Tanimura, Masahiro Okuda
In spite of current recommended safe handling procedures, the potential for the exposure of healthcare providers to hazardous drugs exists in the workplace. A reliance on biological safety cabinets to provide total protection against the exposure to hazardous drugs is insufficient. Preventing workplace contamination is the best strategy to minimize cytotoxic drug exposure in healthcare providers. This study was conducted to compare surface contamination and personnel exposure to cyclophosphamide before and after the implementation of a closed-system drug transfer device, PhaSeal, under the influence of cleaning according to the Japanese guidelines...
December 2013: SpringerPlus
Lorena De Ausen, Erik F DeFreitas, Latisha Littleton, Michael Lustik
PURPOSE: A study of leakage from selected closed-system transfer devices (CSTDs) under experimental conditions is described. METHODS: Three CSTDs (the ChemoClave, OnGuard, and PhaSeal systems) were tested. Nine manufacturer-trained oncology pharmacists and pharmacy technicians volunteered to participate in an experiment to determine the degree of leakage of a liquid test agent (a radioactive technetium isotope [(99m)Tc] diluted in normal saline) during CSTD-assisted transfer of liquid from vials to syringes per standard practices...
April 1, 2013: American Journal of Health-system Pharmacy: AJHP
J Sánchez-Rubio Ferrández, M C Lozano, I Iglesias, L Sánchez-Rubio Ferrández, B Rodríguez Vargas, R Moreno Díaz
PhaSeal is a closed-system drug transfer device which has demonstrated to protect against occupational exposure to antineoplastic agents. Our aim was to assess the impact of the incorporation of PhaSeal on the processing time of chemotherapy. The study was a prospective simulation study which compared the processing times with the traditional open-system technique and using the closed-transfer system. Four experienced pharmacy technicians prepared six batches with each method simulating simple chemotherapy admixture operations...
September 2012: International Journal of Pharmaceutical Compounding
Thomas Queruau Lamerie, Laurent Carrez, Bertrand Décaudin, Lucie Bouchoud, Jean-François Goossens, Christine Barthélémy, Pascal Bonnabry, Pascal Odou
PURPOSE: Evaluation of containment safety devices designed and introduced to protect preparers and administrators of hazardous drugs, through a multiple-test assessment. METHODS: Six devices were compared: (1) Kis1 gravity-fed infusion set (Doran International, France), (2) Tevadaptor Spike Port Adapter (Teva Pharma AG, France), (3) Phaseal Infusion Adapter C100 (Carmel Pharma AB, France), (4) Codan Connect Z (Codan, France), (5) Pchimx with or without a cap (Doran International, France), and (6) Clave extension set 011-H1225 with or without Spiros (Hospira, France)...
June 2012: Journal of Oncology Pharmacy Practice
P Le Garlantezec, N Rizzo-Padoin, O Aupee, V Lamand, H Broto, D Almeras
INTRODUCTION: The exposure of workers to antineoplastic agents is potentially dangerous in the long term because of the teratogenic, carcinogenic and mutagenic hazardous of these products. These risks could be reduced by individual and collective shield measures. It's recommended to use transfer devices in a closed system for preparation of chemotherapy. METHOD: The aim of the survey is to analyse for five devices (four devices in a closed system transfer and a needle equipped with an air intake), the following criteria: transfer performance of a solution of a vial to another one, no leakage of the device and practicality in the use...
May 2011: Annales Pharmaceutiques Françaises
B Favier, H Labrosse, L Gilles-Afchain, C Cropet, D Perol, N Chaumard, J F Latour, P Hild
PURPOSE: The primary objective of this study was to compare the levels of environmental contamination before and after the introduction of PhaSeal® (closed-system drug transfer device) in two hospital pharmacies. Our secondary objective was to assess the impact of the device on the duration of drug preparation compared to procedures involving the use of needles and syringes. METHODS: The study involved two French hospitals, which prepared antineoplastic chemotherapy using a biological safety cabinet and an isolator...
March 2012: Journal of Oncology Pharmacy Practice
Junya Sato, Nao Odagiri, Kazufumi Terui, Yumi Iwasaki, Emi Hosoya, Makoto Hayakari
The recent guidelines of the Japanese Society of Hospital Pharmacists on the antitumor drug preparation have recommended the use of closed systems such as the PhaSeal® system for preventing cytotoxicity in health care workers involved in the preparation of these drugs. The PhaSeal® system and Clave® Oncology system were evaluated using a practical training kit for the preparation of antitumor drugs. The two systems were compared in terms of handling time, satisfaction as to availability, leakage of drugs from the connections in the system and area of drug spillage because improvements in convenience or lower cost system were available...
September 2010: Gan to Kagaku Ryoho. Cancer & Chemotherapy
Koji Hama, Noriaki Kitada, Koichi Fukushima, Tohru Hashida, Kazusaburo Kataoka
PURPOSE: Three products can be used in Japan for the reconstitution of cytotoxic agents: PhaSeal, Chemo CLAVE and Chemo Mini Spike (CMS). The low preparation volume may be affected by residual-related volume in their devices. In this study, the residual-related error in their devices was examined and compared. METHOD: The blank of each component of these devices was weighed using a precision electric balance. After ejecting distilled water (DW) for injection, each was weighed again with the balance...
March 2011: Journal of Oncology Pharmacy Practice
Paul J M Sessink, Thomas H Connor, James A Jorgenson, Timothy G Tyler
PURPOSE: Surface contamination with the antineoplastic drugs cyclophosphamide, ifosfamide, and 5-fluorouracil was compared in 22 US hospital pharmacies following preparation with standard drug preparation techniques or the PhaSeal® closed-system drug transfer device (CSTD). METHODS: Wipe samples were taken from biological safety cabinet (BSC) surfaces, BSC airfoils, floors in front of BSCs, and counters and analyzed for contamination with cyclophosphamide, ifosfamide, and 5-fluorouracil...
March 2011: Journal of Oncology Pharmacy Practice
Jim Siderov, Sue Kirsa, Robert McLauchlan
BACKGROUND: The potential for staff exposure to antineoplastic agents exists in the workplace despite current recommended safe handling procedures. Reliance on cytotoxic drug safety cabinets (CDSC) to provide total protection from exposure to hazardous drugs is insufficient. Preventing workplace contamination is the best strategy to minimise exposure. PhaSeal is a commercially available system for ensuring the leak-free transfer of hazardous drugs, fitting both the NIOSH and ISOPP definitions of a closed system...
March 2010: Journal of Oncology Pharmacy Practice
K De Prijck, E D'Haese, J Vandenbroucke, W Coucke, H Robays, H J Nelis
AIMS: To evaluate the susceptibility to microbial contamination that occurs during simulated handling of protective devices for the preparation of cytotoxic drug solutions. METHODS AND RESULTS: Four devices, i.e. Chemoprotect spike, Clave connector, PhaSeal and Securmix were challenged with low and high inocula of micro-organisms. The cells, transferred to the connected vials during repeated manipulations of the devices were counted by means of solid-phase cytometry...
December 2008: Letters in Applied Microbiology
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